Unchanged
Country not established
- Devices
- 1
What Unchanged makes
The company manufactures the KRONUS OPTIQUANT THYROGLOBULIN KIT, an in vitro diagnostic device used for quantifying thyroglobulin levels in blood samples. This assay supports the monitoring of thyroid cancer patients, particularly those undergoing treatment for differentiated thyroid carcinoma.
The device falls under Class II regulation in the US and is listed in the FDA’s 510(k) clearance registry. The manufacturer operates from the United States.
Catalogue
Kronus Optiquant Thyroglobulin Kit Ref K991720
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unchanged have in the registry?
The registry currently lists 1 device for Unchanged. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unchanged's devices?
Among its 1 most recently registered device, Unchanged has devices listed in FDA 510(k) (1 device).
What risk classes do Unchanged's devices fall under?
Among its 1 most recently registered device, the classes recorded for Unchanged's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unchanged in the registry?
The most recently registered devices listed for Unchanged include KRONUS OPTIQUANT THYROGLOBULIN KIT.